Medical packaging made in a cleanroom
From ventilator masks and filter housings to dental cartridges and implant packaging: We develop and manufacture custom plastic solutions for medical products and medical devices - as a contract manufacturer, in compliance with GMP and certified to DIN EN ISO 13485.
Fully automated production takes place in a cleanroom compliant with DIN EN ISO Class 7 / GMP Standard C - from the concept phase through validation to series production. In-house tooling is included.
Baby flow mask
ventilation mask for infants
Inhalation mask
for children
Filter housing
with 2K lid
dental cartridges
manufactured using precision injection molding
Implant packaging
for dental applications
Breathing filters
for HME filters
Primary and secondary packaging: GMP-compliant, ISO 13485-certified, manufactured in a cleanroom.
From ventilator masks to filter housings to dental applications: We manufacture custom plastic solutions for medical products and medical devices, fully automated in a cleanroom compliant with ISO Class 7 / GMP Standard C and certified to DIN EN ISO 13485. From prototype development to series production - everything from a single source.
Our Added Value,
Your Benefits.
MICHAEL HOLLFELD
Your BENEFIT: Everything from a single source.
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Custom Development: Primary and secondary packaging for medical devices, tailored to your requirements
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Contract Manufacturing: From the concept phase to series production, GMP-compliant
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Fully Automated Cleanroom: Compliant with DIN EN ISO Class 7 / GMP Standard C
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GMP-Compliant Documentation: Certified according to DIN EN ISO 13485
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In-house tooling: custom modifications, fast and flexible
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We would be glad to present our advantages to you in a personal meeting.
From concept to series production:
Our development process for medical devices.
Every medical device is unique. That’s why we support you from the initial requirements analysis through to validated mass production, with seamless quality management in accordance with DIN EN ISO 13485 and complete GMP-compliant documentation.
Requirements
Analysis
Joint definition of specifications, standards, and project goals.
Design &
Prototyping
CAD development and initial prototypes from our in-house toolmaking department.
Validation
DQ, IQ, OQ, PQ in accordance with GMP standards, fully documented.
Series Production
Fully automated cleanroom production in accordance with ISO Class 7 and GMP Standard C.
